Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202112813900074 Date of Approval: 14/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prophylactic Cryoprecipitate Transfusion in patients undergoing Scoliosis Surgery: A randomized-controlled trial
Official scientific title Prophylactic Cryoprecipitate Transfusion in patients undergoing Scoliosis Surgery: A randomized-controlled trial
Brief summary describing the background and objectives of the trial Background: Surgical correction of scoliosis can be associated with substantial perioperative bleeding that may require transfusion of multiple units of erythrocytes and other blood components. Intraoperative transfusion requirements are not necessarily predicted by the cause of scoliosis or preoperative laboratory assessment of coagulation. Replacement for massive intraoperative bleeding (more than 50% total blood volume) with crystalloid and packed erythrocytes (PEs) during scoliosis correction can dilute the coagulation factors and further increase surgical bleeding. (1) During major surgery extensive blood loss is frequent. Clot formation is essential in reaching and maintaining hemostasis. Fibrinogen has been found to be the first clotting factor to fall below critical levels during major hemorrhage. (2) It is thus evident that fibrinogen levels are invaluable in the hemostasis process and that a deficiency can lead to serious complications during major surgery. Administration of cryoprecipitate is the most common way to supplement a patient with fibrinogen. This method is used in North America and in the United Kingdom, with other countries using lyophilized fibrinogen concentrates instead (3). The administration of fibrinogen concentrate, guided by peri-operative thromboelastography, resulted in reduced blood transfusions, particularly considering platelets and FFP requirements.(4) Consequently, some authors advocate either prophylactic or goal-directed fibrinogen concentrate administration to minimize bleeding and reduce blood transfusions in pediatric and adult patients undergoing craniofacial or cardiac surgery, or trauma resuscitation.(5) However, no randomized placebo-controlled trial has been performed to evaluate prophylactic transfusion of cryoprecipitate as a natural source of fibrinogen in scoliosis surgery. 2 Aim of the study: The study will be conducted to investigate whether prophylactic administration of Cryoprecipitate is
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2021
Actual trial start date 01/03/2021
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group the cryoprecipitate group during the whole stay at the hospital the cryoprecipitate group, which will receive after induction of anesthesia, intra-operative cryoprecipitate, 30
Control Group the placebo group the whole stay at the hospital. the placebo group, which will receive an equal fluid volume (in ml) of physiological saline (NaCl 0.9%) at the same time points. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA grade I-III, adolescents who were to undergo major elective scoliosis surgery expected to last at least 4 hours bleeding disorder, pre-existing thrombocytopenia and/or anemia, prior thromboembolic disease, hemorrhagic diathesis, established hypersensitivity to fibrinogen concentrate, active infectious disease, overweight (BMI>35), left ventricular ejection fraction below 45%, significant cardiac arrhythmias, valvular lesions, perioperative renal insufficiency, impaired hepatic function, allergy to any drug used in this study, preoperative infection and intake of acetylsalicylate within 2 weeks or nonsteroidal anti-inflammatory drugs within 7 days before surgery Adolescent: 13 Year-18 Year 13 Year(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/09/2021 ethics committee Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion st, elmessalah,Alexandria, Egypt Alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary endpoint was the volume of peri-operative transfused blood products (pRBCs, FFP and concentrated platelets) during the whole stay in hospital. during the whole stay in hospital
Secondary Outcome A secondary endpoint was the volume of peri-operative blood loss, defined as the sum of the blood loss measurements during surgery, and the precisely measured volume of postoperative blood loss during the stay on the ICU. during the stay on the ICU.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Hadara University Hospita El Hadra, Alexandria, Egypt Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rabab saber Elsayed MAHRUS 33 B ahaa ElDin Elghatwary st. Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rabab Saber Mahrous 33 Bahaa ElDin st, Smouha Alexandria 21647 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rabab Mahrous roba98@hotmail.com 00201223497339 33 Bahaa Eldin Elghatwary st, Smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Assistant professor of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Tarek Ismael drtarek.anesth@gmail.com 00201227392464 Smouha
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Anesthesia Helwan University
Role Name Email Phone Street address
Public Enquiries Rabab Mahrous roba98@hotmail.com 00201223497339 33 Bahaa Eldin Elghatwary st, Smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Assistant prof of Anesthesia Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes - Will individual participant data be available (including data dictionaries)? Yes - What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification - What other documents will be available? Study Protocol - When will data be available (start and end date) Immediately following publication, for 1 year. - With who? Anyone who wishes to access the data - For what types of analyses? Any purpose - By what mechanism will date be made available Data are available by a link that will be provided after completion. Study Protocol Immediately following publication, for 1 year. open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information